PMID: 11337148May 5, 2001Paper

Stabilization of eptifibatide by cosolvents

International Journal of Pharmaceutics
L Zhao, S H Yalkowsky

Abstract

Eptifibatide is a potent and highly specific inhibitor of platelet receptor glycoprotein IIb/IIIa and is indicated in the treatment of acute coronary syndrome. The commercial product Integrilin(R) (eptifibatide) Injection requires a cold/refrigerator storage condition. In an effort to improve the drug stability for room temperature storage and transportation, this study proposed a semi-aqueous formulation that contains 2 mg/ml eptifibatide, 10% ethanol, 40% propylene glycol and 50% 0.025 M citrate buffer. The stability study was conducted in the pH range 4.25-6.25 under accelerated temperatures: 48, 60, 72.5 degrees C. The results indicate that the proposed semi-aqueous vehicles substantially increased the drug stability in comparison with aqueous vehicles. The predicted drug shelf-life T(90) at 25 degrees C shows that an almost twofold increase can be achieved by formulating eptifibatide in the semi-aqueous vehicle, which is 60 months at its maximum stability of pH 5.75, as opposed to the 33 months in the aqueous vehicle at its maximum stability of pH 5.25.

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Citations

Nov 16, 2002·International Journal of Pharmaceutics·Nina NiSamuel H Yalkowsky
Jun 24, 2011·Drug Development and Industrial Pharmacy·Rohit JainIan G Tucker
May 12, 2010·Heart & Lung : the Journal of Critical Care·Emile HayJamal Jafari
Dec 12, 2018·Luminescence : the Journal of Biological and Chemical Luminescence·Eman Saad ElzanfalyHala Elsayed Zaazaa
Jun 24, 2005·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Kamlesh Patel, Marcie J Hursting
Apr 21, 2019·Journal of Chromatographic Science·Eman Saad ElzanfalyHala Elsayed Zaazaa

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